Devices & Diagnostics Letter

Companies developing companion drugs and in vitro diagnostics (IVD) should hold joint meetings with CDRH and the Center for Drug Evaluation and Research (CDER) as early as possible and ensure that drug and diagnostic development timelines are aligned, Linda Burdette, director of regulatory affairs at Hoffmann-La Roche, said Tuesday at the Cambridge Health Institute’s Regulatory Compliance in Drug-Diagnostic Co-Development conference.

Medical technology trade groups are pressuring the Centers for Medicare & Medicaid Services (CMS) to immediately release the nearly year-late Physician Payment Sunshine Act final rule, but want the agency to hold off on collecting data on manufacturer and group purchasing organization payments to doctors until 180 days after the rule’s debut.

Companies could get a better idea of what the FDA expects in postapproval studies (PAS) required as part of a device’s approval at an Aug. 30 agency workshop.

Revising the role and transparency of notified bodies in the EU’s medical device approval process could be the centerpiece of the European Commission’s recast of the medical device directives (MDD).

Medicare will cover patients enrolled in Medtronic’s pivotal trial of the CoreValve system, under an Aug. 10 revision to the Centers for Medicare & Medicaid Services’ (CMS) coverage policy on transcatheter aortic valve replacement (TAVR).

Device industry groups are in negotiations with the Centers for Medicare & Medicaid Services (CMS) to get the agency to reconsider a policy memo on hospital equipment maintenance requirements.

Medtronic will continue to focus on increased penetration in emerging markets, despite missing a target of 20 percent growth in countries such as India and China, CEO Omar Ishrak said in a Tuesday earnings call.

Makers of Class IV devices that choose not to use a summary technical documentation (STED)-based license or amendment application must provide details on manufacturing and quality controls, a device-specific quality plan and process validation studies, according to a Health Canada final guidance.

A majority of U.S. hospitals could be utilizing medical device integration software (MDI) within the next five years, a recent study suggests.

Standards for ventilator safety and performance, vena cava filters and medical device software lifecycle processes are among those added or updated in an FDA document published in Tuesday’s Federal Register.